A Phase 1 Placebo-Controlled Randomized Observer-Blind Dose-Finding Study To Evaluate The Safety Tolerability And Immunogenicity Of Self-Amplifying RNA Vaccine Preparations Against Influenza In Healthy Individuals

Brief description of study

The purpose of this study is to see if a new type of influenza vaccine, called Self-Amplifying RNA (saRNA) Vaccine Preparation -similar to mRNA vaccines, is safe and can help the body produce antibodies which may help fight off influenza. Different types of saRNA vaccine preparation will be used in this study. The researchers will test this type of vaccine using several types of preparation as each influenza saRNA vaccine preparation is investigational (not approved by health authorities). These preparations are not anticipated to provide protection against flu. The study will ask you not receive another influenza vaccine until you have completed your participation in the study. It is anticipated that 5 different types of vaccine preparations will be studied at 3 or more dose levels, although it is possible other preparations and dose levels may be added.


Clinical Study Identifier: s22-00165
ClinicalTrials.gov Identifier: NCT05227001
Principal Investigator: Angelica Cifuentes Kottkamp.
Other Investigators: Ellie R. Carmody, Tamia Davis, Sean P. Heffron, Lalitha Parameswaran, Irma Noriega, Celia Engelson, Mark J. Mulligan.


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